SYNFLORIX 3 MCG / 0.5 ML
PNEUMOCOCCAL POLYSACCHARID SEROT. 19F CONJUG. TO DIPHTHERIA TOXOID CARRIER PROT. : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACC. SEROT. 18C CONJUG. TO TETANUS TOXOID CARRIER PROT. : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML · DIN 02320541 · GLAXOSMITHKLINE INC
Health Canada status: CANCELLED POST MARKET
What is SYNFLORIX?
SYNFLORIX 3 MCG / 0.5 ML contains PNEUMOCOCCAL POLYSACCHARID SEROT. 19F CONJUG. TO DIPHTHERIA TOXOID CARRIER PROT. : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACC. SEROT. 18C CONJUG. TO TETANUS TOXOID CARRIER PROT. : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02320541, held by GLAXOSMITHKLINE INC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as cancelled post market, status dated 30-Sep-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is SYNFLORIX used for?
Active immunization of infants and children 6 weeks to 5 years against Streptococcus pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and 19A) causing invasive disease, pneumonia, and AOM.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02320541 |
|---|---|
| Brand name | SYNFLORIX |
| Generic / active ingredient | PNEUMOCOCCAL POLYSACCHARID SEROT. 19F CONJUG. TO DIPHTHERIA TOXOID CARRIER PROT. : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACC. SEROT. 18C CONJUG. TO TETANUS TOXOID CARRIER PROT. : 3 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D CARRIER PROTEIN : 1 MCG / 0.5 ML |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 3 MCG / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07AL02 PNEUMOCOCCUS, PURIFIED POLYSACC.ANTIGEN CONJUGATED |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 30-Sep-2025 |
| Original market date | 2009-05-22 00:00:00 |
How is it administered?
0.5 mL intramuscular injection. Infants: 3-dose primary series (2, 4, 6 months) or 2-dose (2, 4 months) with a booster at 11-15 months. Catch-up schedules available for children up to 5 years.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 2°C to 8°C. Do not freeze. (Note: General storage section 11 mentioned in TOC, but specific temp in text often 2-8°C for vaccines; inferred from standard vaccine practice).
How is it supplied?
0.5 mL suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles in pack sizes of 1 or 10.
Contraindications
Known hypersensitivity to any component of the vaccine.
Warnings and precautions
Do not administer intravascularly or intradermally. Postpone in acute severe febrile illness. Caution in individuals with thrombocytopenia or coagulation disorders. Syncope can occur.
What can be used instead?
Other Canadian products sharing ATC code J07AL02 PNEUMOCOCCUS, PURIFIED POLYSACC.ANTIGEN CONJUGATED. 3 of 10 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| CAPVAXIVE | 4 MCG / 0.5 ML | SOLUTION | MERCK CANADA INC | MARKETED | DIN 02549891 |
| PREVNAR 20 | 2.2 MCG / 0.5 ML | SUSPENSION | PFIZER CANADA ULC | MARKETED | DIN 02527049 |
| VAXNEUVANCE | 30 MCG / 0.5 ML | SUSPENSION | MERCK CANADA INC | MARKETED | DIN 02522403 |
| PNEUMO 23 | 25 MCG / 0.5 ML | LIQUID | SANOFI PASTEUR LIMITED | CANCELLED POST MARKET | DIN 02231259 |
| PNEUMOVAX 23 | 25 MCG / 0.5 ML | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 00431648 |
| PNEUMOVAX 23 -(5-DOSE) | 25 MCG / 0.5 ML | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | DIN 02240632 |
| PNU-IMUNE 23 | 25 MCG / 0.5 ML | LIQUID | LEDERLE LABS, DIVISION OF AMERICAN CYANAMID CO | CANCELLED POST MARKET | DIN 02230175 |
| PREVNAR | 20 MCG / 0.5 ML | SUSPENSION | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 02244081 |
| PREVNAR 13 | 2.2 MCG / 0.5 ML | SUSPENSION | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 02335204 |
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.